N/A
N=344
Non-Interventional Study on the Tolerability and Efficacy of IVIG
Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
Bottom Line
View on ClinicalTrials.gov: NCT02303093 ↗Enrolled (actual)
344
Serious AEs
1.4%
Results posted
Jun 2021
Primary outcome: Primary: Adverse Drug Reactions — 17; 37; 0; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Octagam IVIG 5% or 10% (Biological); Panzyga (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Octapharma
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Drug Reactions |
17; 37; 0; 1; 9; 9 | — |
| SECONDARY Infection Occurrence |
20; 61; 2; 0; 7; 31 | — |
Summary
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%
Eligibility Criteria
Inclusion Criteria
- Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02303093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.